Bristol Myers Squibb (NYSE:BMY) and bluebird bio Inc (Nasdaq:BLUE) said on Wednesday that they have resubmitted their Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for a potential treatment for adult patients with relapsed and refractory multiple myeloma.
The BLA concerns idecabtagene vicleucel (ide-cel; bb2121), the companies' investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy. It follows the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of ide-cel in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory (IMiD) agent, a proteasome inhibitor (PI) and an anti-CD38 antibody.
This submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the FDA's outstanding regulatory requests after the original BLA submission in March 2020.
Ide-cel has been granted Breakthrough Therapy Designation (BTD) by the FDA, and PRIority MEdicines (PRIME) designation and validation of its Marketing Authorization Application (MAA) by the European Medicines Agency for relapsed and refractory multiple myeloma.
At present, ide-cel is not approved for any indication in any country.
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